INTRODUCTIONThis micro-electronic implant communicates with the scanning handpiece , allowing the surgeon to identify the exact tissue (and how much of it) to extract during a a lumpectomy . The early process of localization came in the form of a guide wire insert but later advancements offered other solutions including a wireless radioactive seed and (then) a non-radioactive version c-SCOUT", developed by Cianna Medical and then acquired by MERIT MEDICAL, an American medical technology company in 2018. Our publishers elected to review this surgical solution in support of improvements in the preservation of the breast during surgery. In this feature article, we present Dr. Troy Shell-Masouras of Paradise Coast Breast Specialists in
WIRE-FREE UPGRADE IN LOCALIZED IMPLANTSSCOUT wire-free radar localization was developed by Cianna Medical in 2010 and was an alternative to the predominant guide wire concept. One of the biggest benefits of going wire free is for the patient. Eliminating the wire provides a huge impact on patient satisfaction because the original process includes placing a wire in the patient the day of surgery and they maintain this wire sticking out of their breast until surgery time, which can be several hours.
The genesis of the non-radioactive reflector came about in 2010 as the company started re-evaluating the breast surgery localization space, because at the time there were only two other options available; the guide wire solution (standard for 50+ years) and the radioactive seed alternative. Despite its advantages, the radioactive seed solution showed its own set of limitations and regulatory issues, limiting its public acceptance. "It needed a lot of training and tracking and was restricted to a limited time where you can actually place it."
By December 2014, Cianna Medical received FDA Clearance for the first
generation of SCOUT allowing full
commercialization in the U.S, CE Mark for
Once placed into the region for surgery, the surgeon uses the SCOUT surgical guide which transmits pulsating infrared light and a pulsating radar signal (at 50 million pulses/ sec). This infrared light activates the reflector which bounces the radar signal back to the system, giving an audible cadence when detected as well as distance measurements from the end of that guide, accurate to one millimeter. To simplify, the technology is very similar to the micro power impulse radar used in your backup sensors in automobiles. So it's very accurate in detecting things over very short distances.
Merit attributes their success in tech feature upgrades to collected end user data from the surgical community. Prototypes are underway for a reduced reflector size, advanced image guidance, customized targeting cadence and improved ease of use in installation Since SCOUT is approved for soft tissues it is rapidly expanding into other surgical sites such as pulmonary noduls and soft tissue sarcomas.
FROM THE SURGICAL FIELD
Breast surgeon Dr. Shell-Masouras expands on the benefits of the wire-free (non-radioactive) radar in comparison to the former solutions like the localization wire and radioactive seed. Initially, the first breakthrough into a wireless approach was the radioactive seed - technology that was well-known in prostate cancer. These pellets can be placed into the breast in a similar fashion where the SCOUT reflector would be placed. Once installed, you would use a probe that detects the signal of the seeds. The issue here is that because it is radioactive, there are very strict monitoring and nuclear medicine guidelines on this process as far as its retrieval. To describe this a different way, imagine inserting this radioactive seed in a patient before their surgery-- then if that patient gets into a car accident or disappeared in some way, your entire radioactive seed program could be shut down because you have to be able to retrieve that seed.
There are limitations on how long that seed is active and detectable. Because of these issues, products like SCOUT were developed where there are no limitations on the activity of the device. Time is of no concern if your patient grows ill and their procedure is postponed a month or so down the road. There's no urgency to retrieve the product at any time. These real-life situations are really why products like this are developed.
Comparatively speaking, there appears to be no difference in accuracy between the wired solution, the radioactive seed and the SCOUT . The radioactive seed is significantly smaller than the SCOUT but this size difference is a non-issue to surgeons. Statements about SCOUT’s (minor) limitations however mention a slight adjustment in work parameters around the distance between the skin and the device particularly with large breasts or very dense breasts.
It is noted that programs using radioactive seeds continue to exist, but the market appears to reflect a transition to non-radioactive devices for reasons described.
(R-image) Dr. Troy
Shell-Masouras conducts life saving Breast Cancer Surgery at the Paradise Coast
Breast Specialists in